FDA.reportPublic FDA data

Medique Decorel Forte

Product NDC
47682-435
11-digit product format
476820435
Labeler code
47682
Product ID
47682-435_3e4fe7f8-b07f-5ac2-e063-6394a90afc08
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-26
Substance
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5; 325; 10; 100 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Medique Decorel Forte
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
362O9ITL9DInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1098435Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e64c283b-0efa-0bfd-e053-2a95a90ab71dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-435-36Medique Decorel Forte75 in 1 BOXTABLET, FILM COATED755
47682-435-80Medique Decorel Forte40 in 1 BOXTABLET, FILM COATED405
47682-435-99Medique Decorel Forte2 in 1 PACKETTABLET, FILM COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-435MEDIQUE DECOREL FORTE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED MEDI-FIRST COUGH COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED MEDI-FIRST PLUS COUGH COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4Current NDC, Legacy NDC, 3 package rows20240915_e64c283b-0efa-0bfd-e053-2a95a90ab71d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 23 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Congestion Relief Cooling Nasal MistOXYMETAZOLINE HCLHaleon US Holdings LLC90125a19-eed7-4ca4-a6dc-f38026c74d542026-06-08WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company54254b61-7861-4eeb-bd3c-54fd5266f4a72026-06-08WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINMajor Pharmaceuticalsaa662428-e61f-4e22-af4d-8cf63df68c992026-06-08WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, GUAIFENESIN AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLTARGET CORPORATION47a218a0-6395-36bd-e063-6394a90a265a2026-06-05WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCLTARGET CORPORATION4779288a-9850-8490-e063-6394a90abe512026-06-05WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCLReckitt Benckiser LLC4df37cfb-299f-661f-e063-6394a90ab3372026-06-04WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEBayer HealthCare LLC.53715ea4-42b3-5887-e063-6294a90a42492026-06-04WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association, Inc.b0d38db9-22a9-4dd8-8e0f-dd81805e724b2026-06-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY65d4d7ea-c080-404e-9836-7d6bdcc5ea7d2026-06-04WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfe9d6a6e-38a1-44ae-a30f-596c5ec7d0572026-06-03WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyb0c1d635-0f85-433a-b479-51c68d259faa2026-06-03WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWalgreen Companyde4e8af4-d3d0-44b3-aea3-79016803ccdc2026-06-03WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR AND GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICEdc0a3761-bbe2-4261-a183-594f5fb12b0b2026-06-03WarningsExact identifier
application number: M012
Cold and Flu Daytime, NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALMART INC.f278cc81-65b2-4e45-be5b-41152cbb67c42026-06-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamily Dollar Services Inc358ba91d-06a4-49c9-994d-4e4bf9499dcd2026-06-03WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANCardinal Health 107, LLCc5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed2026-06-02WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5349dbde-730c-610f-e063-6394a90a952a2026-06-02WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATECardinal Health 107, LLCa9130f36-4761-4e6b-a383-eca3db06ea932026-06-02WarningsExact identifier
application number: M012
Topcare Day Time Nite Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCaed387e0-5a8b-4caf-a373-3e04496a49832026-06-02WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.53371691-2510-5039-e063-6394a90a6ea92026-06-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098435acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral TabletPSNe64c283b-0efa-0bfd-e053-2a95a90ab71d5
1098435acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe64c283b-0efa-0bfd-e053-2a95a90ab71d5
1098435APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYe64c283b-0efa-0bfd-e053-2a95a90ab71d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-435-364768204353675 PACKET in 1 BOX (47682-435-36) / 2 TABLET, FILM COATED in 1 PACKET (47682-435-99) 75 packet2022-12-120000-00-00NoNoCurrent
47682-435-804768204358040 PACKET in 1 BOX (47682-435-80) / 2 TABLET, FILM COATED in 1 PACKET (47682-435-99) 40 packet2022-09-260000-00-00NoNoCurrent
47682-435-99476820435992 TABLET, FILM COATED in 1 PACKET (47682-435-99) 2022-09-26NoNoCurrent